Polivy

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polatuzumab vedotin

Authorised
This medicine is authorised for use in the European Union.

Overview

Polivy is a cancer medicine used to treat adults with diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or has stopped responding to other treatments and who cannot have a bone-marrow transplantation.

It is used in combination with two other medicines, bendamustine and rituximab.

DLBCL is rare, and Polivy was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 April 2018. ​

Polivy contains the active substance polatuzumab vedotin.

This EPAR was last updated on 27/01/2020

Authorisation details

Product details
Name
Polivy
Agency product number
EMEA/H/C/004870
Active substance
polatuzumab vedotin
International non-proprietary name (INN) or common name
polatuzumab vedotin
Therapeutic area (MeSH)
Lymphoma, B-Cell
Anatomical therapeutic chemical (ATC) code
L01XC
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Roche Registration GmbH
Date of issue of marketing authorisation valid throughout the European Union
16/01/2020
Contact address

Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

16/01/2020 Polivy - EMEA/H/C/004870 -

Contents

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Pharmacotherapeutic group

  • Monoclonal antibodies
  • Other antineoplastic agents

Therapeutic indication

Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.

Assessment history

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